Phase 4
N=90
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
Influenza Immunization · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05050318 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 — 28; 31; 20; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation (Biological); Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation (Biological)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 |
28; 31; 20; 31; 7; 0 | — |
| PRIMARY Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3 |
30; 30 | — |
Summary
This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than ( =) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.
Eligibility Criteria
Inclusion Criteria
- Aged 6 months to = 65 years of age on the day of first study vaccination (study product administration).
- For infants and toddlers, born at full term of pregnancy (>=37 weeks) or born after a gestation period of 27 through 36 weeks.
- For participants 6 to = 37 weeks) and with a birth weight >= 5.5 pound (lbs) (2.5 kilogram [kg]).
- Informed consent form (ICF) has been signed and dated by participants >= 65 years of age.
- Assent form has been signed and dated by participants 7 to = 100.4° Fahrenheit [38.0° Celsius]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- History of serious adverse reaction to any influenza vaccine.
- Personal history of Guillain-Barré syndrome.
- Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
- Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
- Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
- Receipt of any vaccine in the 30 days preceding the first study intervention administration, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
- Previous vaccination against influenza (in the 2021-2022 influenza season) with an investigational or marketed vaccine.
- Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
- Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Note: Participants might be considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none were planned before the participant would complete safety surveillance for the present study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT05050318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.